Invasive Aspergillosis, Mucormycosis
Conditions
Brief summary
This is a non-interventional medical chart review study aiming to examine the effectiveness, safety, and treatment patterns of isavuconazole in 5 European countries (France, Germany, Italy, Spain, and United Kingdom). Eligible patients are adults who have been treated with isavuconazole in routine practice at participating sites since 15 October, 2015 or since the date of launch in the country if it is after 15 October, 2015 until 30 June, 2019. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.
Detailed description
This observational study will include approximately 600 patients diagnosed with invasive aspergillosis or mucormycosis who received treatment with at least one dose of isavuconazole in the hospital setting. Patients will be recruited in approximately 20 sites across 5 countries in Europe. Patients will be followed from isavuconazole initiation (index event) until six-months post-index treatment discontinuation, death, loss to follow-up, or 31 December, 2019, whichever occurs first. De-identified data on patient demographics, disease characteristics, treatment effectiveness, safety outcomes, isavuconazole treatment patterns, and HCRU will be collected from patient medical records and entered into an electronic data capture (EDC) system by site staff. Follow-up data will include details of treatment over time and clinical, radiological, mycological, and healthcare resource utilization outcomes. As this study is retrospective, information pertaining to patient care will already be documented in patient medical records at the time of chart abstraction.
Interventions
DRUGIsavuconazole
antifungal agent
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized patient must be aged ≥ 18 years at the time of isavuconazole initiation 2. Patient must have a record of a diagnosis of invasive aspergillosis or mucormycosis in their medical record at the time isavuconazole was initiated (regardless of whether this diagnosis is suspected or confirmed ) 3. Patient must have received at least one dose of isavuconazole during the eligibility period (October 15, 2015, to June 30, 2019)
Exclusion criteria
1\. Patients who did not receive at least one dose of isavuconazole for treatment of invasive aspergillosis or mucormycosis within the eligibility period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Clinical Response at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Clinical Response at Week 24 | Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Radiological Response at Week 6 | Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: greater than or equal to (\>=) 50 percent (%) improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 6 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Radiological Response at Week 12 | Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 12 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Radiological Response at Week 24 | Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 24 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Mycological Response at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Mycological Response at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Mycological Response at Week 24 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| All-Cause Mortality at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants who died due to any cause at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| All-Cause Mortality at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants who died due to any cause at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| All-Cause Mortality at Week 24 | Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants who died due to any cause at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Adverse Event at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Adverse Event at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Adverse Event at Week 24 | Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Serious Adverse Event at Week 6 | Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Serious Adverse Event at Week 12 | Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Serious Adverse Event at Week 24 | Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Primary Reason For Inpatient Hospitalization | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants with primary reason for inpatient hospitalization such as other disease monitoring, other, invasive aspergillosis or mucormycosis disease monitoring, AE related to invasive aspergillosis or mucormycosis and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Mean Length of Stay For Inpatient Hospitalization | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Length of stay was computed as the date of discharge from hospital minus the date of hospitalization plus (+) 1. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants According to Method of Administration | At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months | Number of participants according to method of drug administration: infusion, oral and unknown were reported in this outcome measure. |
| Number of Participants According to Location for Inpatient Hospitalization | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants according to location for inpatient hospitalization such as: hematology ward, other ward, intensive care unit, transplantation ward, emergency room, general medicine ward, oncology ward and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Duration between Isavuconazole treatment was defined as the date of inpatient hospitalization minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants According to Dosage of Isavuconazole Administration | At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months | Number of participants according to dosage of drug administration: 200 milligram (mg), other and unknown were reported in this outcome measure. |
| Number of Participants With Therapeutic Drug Monitoring (TDM) | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Isavuconazole Treatment Modification | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Treatment modification was defined as change in dose or dosing schedule of participants who received isavuconazole. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Types of Isavuconazole Treatment Modification | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants with type of treatment modifications required during the index period were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Duration Between Isavuconazole Treatment and Treatment Modification | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Duration between Isavuconazole treatment and treatment modification was defined as the date of first modification minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Percentage of Participants Who Discontinued Isavuconazole Treatment | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Percentage of participants who discontinued Isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Duration of Isavuconazole Treatment | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Duration between Isavuconazole treatment was defined as the date of discontinuation minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants with reasons for Isavuconazole treatment discontinuation were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants Who Switched to New Antifungal | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants who switched to new antifungal therapy after discontinuation of Isavuconazole were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Type of New Antifungal Therapy | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants according to new antifungal therapy after end of isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Isavuconazole Administered as Part of Combination Therapy | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants with index treatment administered as part of antifungal combination therapy were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. one participant could have received more than one treatment |
| Number of Participants Who Received Other Concomitant Treatments | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Concomitant treatments included: Antibiotic agent, corticosteroid agent, chemotherapy, immunosuppressant agent, other and unknown were reported in this outcome measure. One participant could have more than one treatment. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Any Outpatient Visits | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants with any outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Total Number of Outpatient Visits | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Total number of outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Type of Outpatient Visits | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Type of outpatient visit (Health Care Professional Visit or Referral) such as secondary care visit (specialist), secondary care referral (specialist), primary care visit (general practitioner) and emergency room (ER) visit were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Duration between Isavuconazole treatment was defined as the date of first outpatient visit minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
| Number of Participants With Inpatient Hospitalization | From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months) | Number of participants according to index treatment administered in the inpatient setting were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. |
Countries
France, Germany, Italy, Spain, United Kingdom
Participant flow
Recruitment details
Data from the medical records of participants with invasive aspergillosis or mucormycosis who initiated isavuconazole treatment during the index period of 15 October 2015 until 30 June 2019 were included in this study.
Pre-assignment details
Retrospective data was extracted and evaluated from study start date and until study completion (approximately 34 months) of this retrospective observational study. Participants were followed from index date until 6 months post-index treatment discontinuation, death, loss to follow-up, whichever occurs first.
Participants by arm
| Arm | Count |
|---|---|
| Invasive Aspergillosis Participants with aspergillosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group. | 201 |
| Mucormycosis Participants with mucormycosis who received isavuconazole treatment in between 15-Oct-2015 to 30-Jun-2019 under routine clinical practice and whose data were observed in the study, were included in this reporting group. | 17 |
| Total | 218 |
Baseline characteristics
| Characteristic | Invasive Aspergillosis | Mucormycosis | Total |
|---|---|---|---|
| Age, Continuous | 56.0 Years STANDARD_DEVIATION 15.6 | 66.5 Years STANDARD_DEVIATION 12.8 | 56.8 Years STANDARD_DEVIATION 15.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 65 Participants | 9 Participants | 74 Participants |
| Sex: Female, Male Male | 136 Participants | 8 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 127 / 201 | 10 / 17 |
| other Total, other adverse events | 17 / 201 | 2 / 17 |
| serious Total, serious adverse events | 34 / 201 | 3 / 17 |
Outcome results
Primary
All-Cause Mortality at Week 12
Number of participants who died due to any cause at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | All-Cause Mortality at Week 12 | 74 Participants |
| Mucormycosis | All-Cause Mortality at Week 12 | 2 Participants |
Primary
All-Cause Mortality at Week 24
Number of participants who died due to any cause at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | All-Cause Mortality at Week 24 | 93 Participants |
| Mucormycosis | All-Cause Mortality at Week 24 | 5 Participants |
Primary
All-Cause Mortality at Week 6
Number of participants who died due to any cause at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | All-Cause Mortality at Week 6 | 48 Participants |
| Mucormycosis | All-Cause Mortality at Week 6 | 1 Participants |
Primary
Number of Participants With Adverse Event at Week 12
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Adverse Event at Week 12 | 38 Participants |
| Mucormycosis | Number of Participants With Adverse Event at Week 12 | 3 Participants |
Primary
Number of Participants With Adverse Event at Week 24
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Adverse Event at Week 24 | 42 Participants |
| Mucormycosis | Number of Participants With Adverse Event at Week 24 | 3 Participants |
Primary
Number of Participants With Adverse Event at Week 6
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of participants with any adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Adverse Event at Week 6 | 33 Participants |
| Mucormycosis | Number of Participants With Adverse Event at Week 6 | 2 Participants |
Primary
Number of Participants With Clinical Response at Week 12
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 12 | Unknown | 185 Participants |
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 12 | Clinical success | 16 Participants |
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 12 | Clinical failure | 0 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 12 | Unknown | 15 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 12 | Clinical success | 2 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 12 | Clinical failure | 0 Participants |
Primary
Number of Participants With Clinical Response at Week 24
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 24 | Clinical success | 8 Participants |
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 24 | Unknown | 193 Participants |
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 24 | Clinical failure | 0 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 24 | Unknown | 17 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 24 | Clinical success | 0 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 24 | Clinical failure | 0 Participants |
Primary
Number of Participants With Clinical Response at Week 6
Clinical response was evaluated according to the following mutually exclusive modalities: Clinical success, clinical failure and unknown. Clinical success: resolution or partial resolution of all attributable clinical symptoms and physical findings. Clinical failure: no resolution of any attributable clinical symptoms and physical findings and/or worsening. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any clinical response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 6 | Unknown | 173 Participants |
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 6 | Clinical failure | 1 Participants |
| Invasive Aspergillosis | Number of Participants With Clinical Response at Week 6 | Clinical success | 27 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 6 | Clinical failure | 0 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 6 | Unknown | 14 Participants |
| Mucormycosis | Number of Participants With Clinical Response at Week 6 | Clinical success | 3 Participants |
Primary
Number of Participants With Mycological Response at Week 12
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 12 | Unknown | 195 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 12 | Mycological Success: Presumed eradication | 3 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 12 | Mycological Success: Eradication | 3 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 12 | Mycological Failure | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 12 | Mycological Failure | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 12 | Unknown | 17 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 12 | Mycological Success: Eradication | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 12 | Mycological Success: Presumed eradication | 0 Participants |
Primary
Number of Participants With Mycological Response at Week 24
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 24 | Unknown | 198 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 24 | Mycological Success: Presumed eradication | 1 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 24 | Mycological Success: Eradication | 0 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 24 | Mycological Failure | 2 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 24 | Mycological Failure | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 24 | Unknown | 17 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 24 | Mycological Success: Eradication | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 24 | Mycological Success: Presumed eradication | 0 Participants |
Primary
Number of Participants With Mycological Response at Week 6
Mycological response was evaluated according to the following mutually exclusive modalities: Mycological success, mycological failure and unknown. Mycological success: eradication or presumed eradication of the original causative organism cultured. Mycological failure: persistence or presumed persistence. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any mycological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 6 | Unknown | 190 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 6 | Mycological Success: Presumed eradication | 7 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 6 | Mycological Success: Eradication | 4 Participants |
| Invasive Aspergillosis | Number of Participants With Mycological Response at Week 6 | Mycological Failure | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 6 | Mycological Failure | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 6 | Unknown | 17 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 6 | Mycological Success: Eradication | 0 Participants |
| Mucormycosis | Number of Participants With Mycological Response at Week 6 | Mycological Success: Presumed eradication | 0 Participants |
Primary
Number of Participants With Radiological Response at Week 12
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 12 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 12 | Unknown | 190 Participants |
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 12 | Radiological success | 9 Participants |
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 12 | Radiological failure | 2 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 12 | Unknown | 16 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 12 | Radiological success | 1 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 12 | Radiological failure | 0 Participants |
Primary
Number of Participants With Radiological Response at Week 24
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: \>= 50% improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 24 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 24 | Unknown | 195 Participants |
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 24 | Radiological success | 4 Participants |
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 24 | Radiological failure | 2 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 24 | Unknown | 16 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 24 | Radiological success | 0 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 24 | Radiological failure | 1 Participants |
Primary
Number of Participants With Radiological Response at Week 6
Radiological response was evaluated according to the following mutually exclusive modalities: Radiological success, radiological failure and unknown. Radiological success: greater than or equal to (\>=) 50 percent (%) improvement from initial assessment, or improvement of at least 25% from the initial assessment for the follow-up at 6 weeks or if end of treatment occurred before this time. Radiological failure: Failure to meet success criteria. Unknown: if there was not enough documentation to make the classification success or failure. Number of participants with any radiological response at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date or end of treatment, which ever occurred earlier (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 6 | Unknown | 188 Participants |
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 6 | Radiological success | 11 Participants |
| Invasive Aspergillosis | Number of Participants With Radiological Response at Week 6 | Radiological failure | 2 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 6 | Unknown | 14 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 6 | Radiological success | 3 Participants |
| Mucormycosis | Number of Participants With Radiological Response at Week 6 | Radiological failure | 0 Participants |
Primary
Number of Participants With Serious Adverse Event at Week 12
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 12 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 12 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Serious Adverse Event at Week 12 | 30 Participants |
| Mucormycosis | Number of Participants With Serious Adverse Event at Week 12 | 3 Participants |
Primary
Number of Participants With Serious Adverse Event at Week 24
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 24 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 24 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Serious Adverse Event at Week 24 | 34 Participants |
| Mucormycosis | Number of Participants With Serious Adverse Event at Week 24 | 3 Participants |
Primary
Number of Participants With Serious Adverse Event at Week 6
Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. Number of participants with any serious adverse event based on the medical records at Week 6 post index date were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: Week 6 post index date (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Serious Adverse Event at Week 6 | 26 Participants |
| Mucormycosis | Number of Participants With Serious Adverse Event at Week 6 | 2 Participants |
Secondary
Duration Between Isavuconazole Treatment and Treatment Modification
Duration between Isavuconazole treatment and treatment modification was defined as the date of first modification minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Invasive Aspergillosis | Duration Between Isavuconazole Treatment and Treatment Modification | 38.6 Days | Standard Deviation 59.4 |
| Mucormycosis | Duration Between Isavuconazole Treatment and Treatment Modification | 21.5 Days | Standard Deviation 27.6 |
Secondary
Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit
Duration between Isavuconazole treatment was defined as the date of first outpatient visit minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Invasive Aspergillosis | Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit | 63.0 Days | Standard Deviation 78.2 |
| Mucormycosis | Duration Between Isavuconazole Treatment Initiation and First Outpatient Visit | 82.6 Days | Standard Deviation 128 |
Secondary
Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization
Duration between Isavuconazole treatment was defined as the date of inpatient hospitalization minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Invasive Aspergillosis | Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization | 65.2 Days | Standard Deviation 108.8 |
| Mucormycosis | Duration Between Isavuconazole Treatment Initiation and Inpatient Hospitalization | 77.2 Days | Standard Deviation 125.1 |
Secondary
Duration of Isavuconazole Treatment
Duration between Isavuconazole treatment was defined as the date of discontinuation minus the date of isavuconazole treatment initiation. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Invasive Aspergillosis | Duration of Isavuconazole Treatment | 74.4 Days | Standard Deviation 121.7 |
| Mucormycosis | Duration of Isavuconazole Treatment | 115.6 Days | Standard Deviation 97.5 |
Secondary
Mean Length of Stay For Inpatient Hospitalization
Length of stay was computed as the date of discharge from hospital minus the date of hospitalization plus (+) 1. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Invasive Aspergillosis | Mean Length of Stay For Inpatient Hospitalization | 20.8 Days | Standard Deviation 44.3 |
| Mucormycosis | Mean Length of Stay For Inpatient Hospitalization | 20.0 Days | Standard Deviation 23.7 |
Secondary
Number of Participants According to Dosage of Isavuconazole Administration
Number of participants according to dosage of drug administration: 200 milligram (mg), other and unknown were reported in this outcome measure.
Time frame: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants According to Dosage of Isavuconazole Administration | 200 mg | 186 Participants |
| Invasive Aspergillosis | Number of Participants According to Dosage of Isavuconazole Administration | Other | 10 Participants |
| Invasive Aspergillosis | Number of Participants According to Dosage of Isavuconazole Administration | Unknown | 5 Participants |
| Mucormycosis | Number of Participants According to Dosage of Isavuconazole Administration | 200 mg | 17 Participants |
| Mucormycosis | Number of Participants According to Dosage of Isavuconazole Administration | Other | 0 Participants |
| Mucormycosis | Number of Participants According to Dosage of Isavuconazole Administration | Unknown | 0 Participants |
Secondary
Number of Participants According to Location for Inpatient Hospitalization
Number of participants according to location for inpatient hospitalization such as: hematology ward, other ward, intensive care unit, transplantation ward, emergency room, general medicine ward, oncology ward and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | Haematology ward | 61 Participants |
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | Other ward | 40 Participants |
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | Intensive unit care (ICU) | 21 Participants |
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | Transplantation ward | 14 Participants |
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | Emergency room (ER) | 9 Participants |
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | General medicine ward | 9 Participants |
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | Oncology ward | 6 Participants |
| Invasive Aspergillosis | Number of Participants According to Location for Inpatient Hospitalization | Unknown | 2 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | Unknown | 0 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | Haematology ward | 6 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | Emergency room (ER) | 3 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | Other ward | 5 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | Oncology ward | 2 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | Intensive unit care (ICU) | 1 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | General medicine ward | 0 Participants |
| Mucormycosis | Number of Participants According to Location for Inpatient Hospitalization | Transplantation ward | 1 Participants |
Secondary
Number of Participants According to Method of Administration
Number of participants according to method of drug administration: infusion, oral and unknown were reported in this outcome measure.
Time frame: At index date (date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019); retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants According to Method of Administration | Infusion | 105 Participants |
| Invasive Aspergillosis | Number of Participants According to Method of Administration | Oral | 92 Participants |
| Invasive Aspergillosis | Number of Participants According to Method of Administration | Unknown | 4 Participants |
| Mucormycosis | Number of Participants According to Method of Administration | Infusion | 8 Participants |
| Mucormycosis | Number of Participants According to Method of Administration | Oral | 9 Participants |
| Mucormycosis | Number of Participants According to Method of Administration | Unknown | 0 Participants |
Secondary
Number of Participants Who Received Other Concomitant Treatments
Concomitant treatments included: Antibiotic agent, corticosteroid agent, chemotherapy, immunosuppressant agent, other and unknown were reported in this outcome measure. One participant could have more than one treatment. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants Who Received Other Concomitant Treatments | Antibiotic agent | 109 Participants |
| Invasive Aspergillosis | Number of Participants Who Received Other Concomitant Treatments | Corticosteroid agent | 17 Participants |
| Invasive Aspergillosis | Number of Participants Who Received Other Concomitant Treatments | Chemotherapy | 7 Participants |
| Invasive Aspergillosis | Number of Participants Who Received Other Concomitant Treatments | Immunosuppressant agent | 3 Participants |
| Invasive Aspergillosis | Number of Participants Who Received Other Concomitant Treatments | Other | 5 Participants |
| Invasive Aspergillosis | Number of Participants Who Received Other Concomitant Treatments | Unknown | 2 Participants |
| Mucormycosis | Number of Participants Who Received Other Concomitant Treatments | Other | 3 Participants |
| Mucormycosis | Number of Participants Who Received Other Concomitant Treatments | Antibiotic agent | 16 Participants |
| Mucormycosis | Number of Participants Who Received Other Concomitant Treatments | Immunosuppressant agent | 1 Participants |
| Mucormycosis | Number of Participants Who Received Other Concomitant Treatments | Corticosteroid agent | 2 Participants |
| Mucormycosis | Number of Participants Who Received Other Concomitant Treatments | Unknown | 0 Participants |
| Mucormycosis | Number of Participants Who Received Other Concomitant Treatments | Chemotherapy | 2 Participants |
Secondary
Number of Participants Who Switched to New Antifungal
Number of participants who switched to new antifungal therapy after discontinuation of Isavuconazole were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants Who Switched to New Antifungal | 34 Participants |
| Mucormycosis | Number of Participants Who Switched to New Antifungal | 2 Participants |
Secondary
Number of Participants With Any Outpatient Visits
Number of participants with any outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Any Outpatient Visits | 87 Participants |
| Mucormycosis | Number of Participants With Any Outpatient Visits | 9 Participants |
Secondary
Number of Participants With Inpatient Hospitalization
Number of participants according to index treatment administered in the inpatient setting were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Inpatient Hospitalization | 114 Participants |
| Mucormycosis | Number of Participants With Inpatient Hospitalization | 14 Participants |
Secondary
Number of Participants With Isavuconazole Administered as Part of Combination Therapy
Number of participants with index treatment administered as part of antifungal combination therapy were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019. one participant could have received more than one treatment
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Isavuconazole Administered as Part of Combination Therapy | 53 Participants |
| Mucormycosis | Number of Participants With Isavuconazole Administered as Part of Combination Therapy | 27 Participants |
Secondary
Number of Participants With Isavuconazole Treatment Modification
Treatment modification was defined as change in dose or dosing schedule of participants who received isavuconazole. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Isavuconazole Treatment Modification | 24 Participants |
| Mucormycosis | Number of Participants With Isavuconazole Treatment Modification | 2 Participants |
Secondary
Number of Participants With Primary Reason For Inpatient Hospitalization
Number of participants with primary reason for inpatient hospitalization such as other disease monitoring, other, invasive aspergillosis or mucormycosis disease monitoring, AE related to invasive aspergillosis or mucormycosis and unknown were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Other | 31 Participants |
| Invasive Aspergillosis | Number of Participants With Primary Reason For Inpatient Hospitalization | AE related to invasive aspergillosis or mucormycosis | 2 Participants |
| Invasive Aspergillosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Invasive aspergillosis or mucormycosis disease monitoring | 27 Participants |
| Invasive Aspergillosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Unknown | 2 Participants |
| Invasive Aspergillosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Other disease monitoring | 83 Participants |
| Mucormycosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Unknown | 0 Participants |
| Mucormycosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Other disease monitoring | 8 Participants |
| Mucormycosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Other | 6 Participants |
| Mucormycosis | Number of Participants With Primary Reason For Inpatient Hospitalization | Invasive aspergillosis or mucormycosis disease monitoring | 2 Participants |
| Mucormycosis | Number of Participants With Primary Reason For Inpatient Hospitalization | AE related to invasive aspergillosis or mucormycosis | 0 Participants |
Secondary
Number of Participants With Reasons for Isavuconazole Treatment Discontinuation
Number of participants with reasons for Isavuconazole treatment discontinuation were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Death (unrelated to therapy) | 75 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Participant completed planned course of treatment | 40 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Treatment success (resolution of invasive fungal infection) | 33 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Other | 17 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Lack of response to treatment | 12 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Unknown | 9 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Adverse event | 7 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Participant decision (unrelated to AEs) | 3 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Drug-drug interaction | 3 Participants |
| Invasive Aspergillosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Therapeutic drug monitoring | 1 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Participant decision (unrelated to AEs) | 0 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Death (unrelated to therapy) | 2 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Unknown | 1 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Participant completed planned course of treatment | 8 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Therapeutic drug monitoring | 0 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Treatment success (resolution of invasive fungal infection) | 1 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Adverse event | 2 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Other | 1 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Drug-drug interaction | 0 Participants |
| Mucormycosis | Number of Participants With Reasons for Isavuconazole Treatment Discontinuation | Lack of response to treatment | 1 Participants |
Secondary
Number of Participants With Therapeutic Drug Monitoring (TDM)
Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Invasive Aspergillosis | Number of Participants With Therapeutic Drug Monitoring (TDM) | 33 Participants |
| Mucormycosis | Number of Participants With Therapeutic Drug Monitoring (TDM) | 4 Participants |
Secondary
Number of Participants With Type of New Antifungal Therapy
Number of participants according to new antifungal therapy after end of isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Type of New Antifungal Therapy | Liposomal amphotericin B | 10 Participants |
| Invasive Aspergillosis | Number of Participants With Type of New Antifungal Therapy | Caspofungin | 1 Participants |
| Invasive Aspergillosis | Number of Participants With Type of New Antifungal Therapy | Voriconazole | 6 Participants |
| Invasive Aspergillosis | Number of Participants With Type of New Antifungal Therapy | Other | 5 Participants |
| Invasive Aspergillosis | Number of Participants With Type of New Antifungal Therapy | Posaconazole | 12 Participants |
| Mucormycosis | Number of Participants With Type of New Antifungal Therapy | Other | 0 Participants |
| Mucormycosis | Number of Participants With Type of New Antifungal Therapy | Posaconazole | 1 Participants |
| Mucormycosis | Number of Participants With Type of New Antifungal Therapy | Liposomal amphotericin B | 1 Participants |
| Mucormycosis | Number of Participants With Type of New Antifungal Therapy | Voriconazole | 0 Participants |
| Mucormycosis | Number of Participants With Type of New Antifungal Therapy | Caspofungin | 0 Participants |
Secondary
Number of Participants With Types of Isavuconazole Treatment Modification
Number of participants with type of treatment modifications required during the index period were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Number of Participants With Types of Isavuconazole Treatment Modification | Change from infusion to oral capsule | 13 Participants |
| Invasive Aspergillosis | Number of Participants With Types of Isavuconazole Treatment Modification | Dose decrease | 6 Participants |
| Invasive Aspergillosis | Number of Participants With Types of Isavuconazole Treatment Modification | Other | 14 Participants |
| Invasive Aspergillosis | Number of Participants With Types of Isavuconazole Treatment Modification | Change from oral capsule to infusion | 4 Participants |
| Invasive Aspergillosis | Number of Participants With Types of Isavuconazole Treatment Modification | Dose increase | 11 Participants |
| Invasive Aspergillosis | Number of Participants With Types of Isavuconazole Treatment Modification | Frequency increase | 4 Participants |
| Invasive Aspergillosis | Number of Participants With Types of Isavuconazole Treatment Modification | Frequency decrease | 15 Participants |
| Mucormycosis | Number of Participants With Types of Isavuconazole Treatment Modification | Frequency increase | 0 Participants |
| Mucormycosis | Number of Participants With Types of Isavuconazole Treatment Modification | Frequency decrease | 0 Participants |
| Mucormycosis | Number of Participants With Types of Isavuconazole Treatment Modification | Other | 1 Participants |
| Mucormycosis | Number of Participants With Types of Isavuconazole Treatment Modification | Change from infusion to oral capsule | 1 Participants |
| Mucormycosis | Number of Participants With Types of Isavuconazole Treatment Modification | Dose increase | 0 Participants |
| Mucormycosis | Number of Participants With Types of Isavuconazole Treatment Modification | Dose decrease | 1 Participants |
| Mucormycosis | Number of Participants With Types of Isavuconazole Treatment Modification | Change from oral capsule to infusion | 0 Participants |
Secondary
Percentage of Participants Who Discontinued Isavuconazole Treatment
Percentage of participants who discontinued Isavuconazole treatment were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Invasive Aspergillosis | Percentage of Participants Who Discontinued Isavuconazole Treatment | 93.0 Percentage of Participants |
| Mucormycosis | Percentage of Participants Who Discontinued Isavuconazole Treatment | 94.1 Percentage of Participants |
Secondary
Total Number of Outpatient Visits
Total number of outpatient visit (Health Care Professional Visit or Referral) were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Invasive Aspergillosis | Total Number of Outpatient Visits | 103 Outpatient visits |
| Mucormycosis | Total Number of Outpatient Visits | 12 Outpatient visits |
Secondary
Type of Outpatient Visits
Type of outpatient visit (Health Care Professional Visit or Referral) such as secondary care visit (specialist), secondary care referral (specialist), primary care visit (general practitioner) and emergency room (ER) visit were reported in this outcome measure. Index date was defined as date of Isavuconazole treatment initiation anytime in between 15 October 2015 until 30 June 2019.
Time frame: From index date until 6 months after post-index treatment discontinuation, death, or loss to follow-up, whichever occurred first (retrospective data extracted and evaluated from study start date and until study completion, approximately 34 months)
Population: Analysis population included all eligible participants whose data was retrieved and analyzed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Invasive Aspergillosis | Type of Outpatient Visits | Secondary care visit (specialist) | 70 Participants |
| Invasive Aspergillosis | Type of Outpatient Visits | Secondary care referral (specialist) | 15 Participants |
| Invasive Aspergillosis | Type of Outpatient Visits | Primary care visit (general practitioner) | 6 Participants |
| Invasive Aspergillosis | Type of Outpatient Visits | ER visit | 4 Participants |
| Mucormycosis | Type of Outpatient Visits | ER visit | 1 Participants |
| Mucormycosis | Type of Outpatient Visits | Secondary care visit (specialist) | 9 Participants |
| Mucormycosis | Type of Outpatient Visits | Primary care visit (general practitioner) | 0 Participants |
| Mucormycosis | Type of Outpatient Visits | Secondary care referral (specialist) | 1 Participants |